Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

Phase 4 Completed 72 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.

Timeline

Start: 2011-04
Primary completion: 2011-07
Completion: 2011-07

Outcome

Met primary endpoint

paper The primary outcome, POM at 48 h, was statistically significantly lower with DDEA gel (19.5 mm) vs. placebo (56.9 mm) (p < 0.0001). PMID 23964752 ↗

Publications

Predel HG, Giannetti B, Pabst H, Schaefer A, Hug AM, Burnett I. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study. BMC Musculoskelet Disord. 2013 Aug 21;14:250. doi: 10.1186/1471-2474-14-250.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	2 g	Topical

Indications

No indication recorded.